CellCept（mycophenolate mofetil)是FDA批准的药物，用于接受心脏，肝脏或肾脏移植的患者。 一种免疫抑制药物，CellCept的目的是帮助防止患者身体排斥新器官。
据Donate Life称，每年在美国大约有24,000人接受器官移植（每天大约65人），许多人接受CellCept与其他抗排斥药物联合使用。
批准日期:1998年10月1日  公司：Genentech
CELLCEPT(霉酚酸酯 mycophenolate mofetil) 胶囊, 口服
CELLCEPT(霉酚酸酯 mycophenolate mofetil) 片, 口服
CELLCEPT(霉酚酸酯 mycophenolate mofetil)浮液, 口服悬浮液
CELLCEPT（霉酚酸酯 mycophenolate mofetil）注射，静脉使用
美国初步批准：1995年
警告：胚胎胎儿毒性、恶性肿瘤和严重感染请参阅完整装箱警告的完整处方信息。
孕期使用与妊娠早期丢失和先天畸形的风险增加有关。如果有更安全的治疗方案，应避免。必须就怀孕预防和计划向具有生殖潜力的女性提供咨询[见警告和预防措施]。
淋巴瘤和其他恶性肿瘤，特别是皮肤的发展风险增加[见警告和预防措施]。
对感染的敏感性增加，包括机会性感染和有致命后果的严重感染[见警告和预防措施]。
近期重大变化
警告和注意事项:8/2018
作用机理
霉酚酸酯（MMF）口服后被吸收，水解成活性代谢物霉酚酸（MPA）。MPA是肌苷一磷酸脱氢酶（IMPDH）的一种选择性、非竞争性和可逆抑制剂，因此在不并入DNA的情况下抑制鸟苷核苷酸合成的从头途径。由于T淋巴细胞和B淋巴细胞对嘌呤从头合成的增殖有着至关重要的依赖性，而其他类型的细胞可以利用补救途径，因此mPA对淋巴细胞具有有效的细胞抑制作用。mPA抑制T淋巴细胞和B淋巴细胞对有丝分裂和同种异体刺激的增殖反应。加入鸟苷或脱氧鸟苷可逆转MPA对淋巴细胞的细胞抑制作用。MPA也抑制B淋巴细胞形成抗体。MPA可防止淋巴细胞和单核细胞糖蛋白的糖基化，这些蛋白与内皮细胞的细胞间粘附有关，并可能抑制白细胞向炎症部位的募集和移植排斥反应。MMF不抑制人外周血单个核细胞的早期活动，如白细胞介素-1（IL-1）和白细胞介素-2（IL-2）的产生，但确实阻止了这些活动与DNA合成和增殖的耦合。
适应症和使用
Cellcept是一种抗代谢免疫抑制剂，用于预防同种异体肾、心脏或肝脏移植受者的器官排斥反应，应与其他免疫抑制剂联合使用。
剂量和给药
每日两次口服或静脉注射，不少于2次
成人                                     加药
肾移植             1g，每日两次，口服或静脉注射（iv）不少于2次
心脏移植           1.5g，每日两次口服或静脉注射，不少于2次
肝移植             1.5g，每日两次口服或1g，每日两次静脉注射，时间不少于2次
儿科学
肾移植             600毫克/平方米口服，每日两次，最高每日2克
当病人不能忍受口服药物时，可以选择静脉注射。移植后24小时内给药，直到患者能耐受口服药物，最多14天。
中性粒细胞减少或中断给药。
有关：肾损害和中性粒细胞减少的调整、口服混悬液和静脉输液的制备，请参阅完整的处方信息（FPI）。
剂型及强度
胶囊:250毫克
药片：500毫克
悬浮液：20 g霉酚酸酯莫非替，重组粉
静脉注射：为500毫克，霉酚酸酯盐酸盐为单次使用
禁忌症
对霉酚酸酯、莫菲特、MPA酸或任何药物成分过敏
对多山梨酸盐80过敏的患者（存在于Cellcept IV中）
警告和注意事项
失血症（中性粒细胞减少症，红细胞再生障碍）：通过血液测试进行监测；考虑中断治疗或减少剂量。
胃肠道并发症：监测并发症，如出血、溃疡和穿孔，特别是在有潜在胃肠道疾病的患者中。
次黄嘌呤鸟嘌呤磷酸核糖转移酶缺乏：避免使用赛尔赛普
免疫：避免减毒活疫苗
快速静脉给药的局部反应：不能通过快速或大剂量静脉注射给药Cellcept。
苯丙酮类药物：口服混悬液含有阿斯巴甜。
献血：治疗期间及治疗后6周内避免献血。
精液捐献：在治疗期间和治疗后90天内避免。
不良反应
临床试验中最常见的不良反应（20%或更高）包括腹泻、白细胞减少、感染、呕吐，并且有证据表明某些类型感染的频率更高，例如机会性感染。
药物相互作用
有关可能干扰全身暴露和降低Cellcept疗效的药物，请参阅FPI：与镁或氢氧化铝抗酸，质子泵抑制剂，干扰肠肝循环的药物，替米沙坦，无钙磷酸盐粘合剂。
Cellcept可能会降低口服避孕药的效果。建议使用其他屏障避孕方法。
其他重要药物相互作用见FPI。
在特定人群中使用
儿科应用：同种异体心脏或肝脏移植的安全性和有效性尚未确定。
男性患者：建议性行为活跃的男性患者和/或其女性伴侣在治疗男性患者期间以及停止治疗后至少90天内采取有效的避孕措施。
包装供应/储存和搬运
处理和处置
霉酚酸酯（MMF）已证明对人类有致畸作用[见警告和预防措施和特定人群的使用]。Cellcept片剂不应压碎，Cellcept胶囊不应打开或压碎。建议在重组过程中以及重组后擦拭瓶/盖和桌子的外表面时戴上一次性手套。避免吸入或直接接触Cellcept胶囊、Cellcept口服混悬液（组成前后）或Cellcept静脉注射（制备期间或之后）中所含粉末的皮肤或粘膜[见剂量和给药]。遵循适用的特殊处理和一次性程序。
Cellcept（霉酚酸酯莫非替胶囊）250毫克
胶囊
蓝色褐色硬明胶胶囊，两件，印刷在黑色与蓝色的“骁悉250”和“罗氏”帽布朗的身体。
尺寸
100瓶      NDC 0004-0259-01
500瓶      NDC 0004-0259-43
保管部
储存在25°C（77°F）；允许偏离15°C至30°C（59°F至86°F）
Cellcept（霉酚酸酯莫非替片）500毫克
片
薰衣草色，帽状，薄膜包衣，黑色印刷，一面印有“Cellcept 500”，另一面印有“Roche”。
尺寸
100瓶      NDC 0004-0260-01
500瓶      NDC 0004-0260-43
储存和分配信息：
储存在25°C（77°F）；允许偏离15°C至30°C（59°F至86°F）。
在耐光容器中分配，例如制造商的原始容器
Cellcept口服混悬液（霉酚酸酯口服混悬液）
悬浮液：白色至灰白色粉末混合物，构成白色至灰白色混合果香悬浮液。
225毫升瓶，带瓶适配器和2个口服分配器   NDC 0004-0261-29
保管部
在25°C（77°F）下储存干粉；允许偏离15°C至30°C（59°F至86°F）。
在25°C（77°F）下储存合成悬浮液；允许偏离15°C至30°C（59°F至86°F）长达60天。可在2°至8°C（36°至46°F）的冰箱中储存。不要冻僵。
Cellcept静脉注射（注射用盐酸莫非替尼霉酚酸酯）
注射用霉酚酸酯：500毫克的盐作为盐酸盐在20毫升无菌瓶cartons 4 vials
4瓶       NDC 0004-0298-09
保管部
在25°C（77°F）下储存粉末和重组输液溶液；允许偏离15°C至30°C（59°F至86°F）。
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=37241e87-4af4-4dc3-a1aa-ea6f20d8dc40 
CellCept(mycophenolate mofetil)
Indication
CellCept® (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets, and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.
Important Safety Information Including BOXED WARNINGS
WARNING: EMBROYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS
Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients should prescribe Cellcept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
CONTRAINDICATIONS
CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
WARNINGS
•Pregnancy category D: Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant female. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning
•Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, as part of an immunosuppressive regimen are at increased risk of developing lymphomas and other malignancies, particularly of the skin
•CellCept has been administered in combination with the following agents in clinical trials: antithymocyte globulin, OKT3, cyclosporine, and corticosteroids. The efficacy and safety of the use of CellCept in combination with other immunosuppressive agents have not been determined
•Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, which may lead to serious, including fatal outcomes, combination immunosuppressant therapy should be used with caution
•Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including CellCept. Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft
•Monitor patients for neutropenia. If neutropenia develops [absolute neutrophil count (ANC)
•Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressive agents
•CAUTION: CELLCEPT INTRAVENOUS SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION
PRECAUTIONS
•Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning
◦Pregnancy Testing: a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL must be administered immediately before starting CellCept. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. In the event of a positive pregnancy test, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations, please report the pregnancy to Mycophenolate Pregnancy Registry (1-800-617-8191)
◦Contraception: Patients taking CellCept must receive contraceptive counseling and use acceptable contraception (see Table 8 of the full Prescribing Information for acceptable contraception methods). Patients must use acceptable birth control during entire CellCept therapy, and for 6 weeks after stopping CellCept, unless the patient chooses abstinence
•CellCept may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks
•A higher incidence of opportunistic infections was observed in cardiac transplant patients treated with CellCept than in those receiving azathioprine therapy
•CellCept should not be administered concomitantly with azathioprine and used with caution when used in the concomitant administration with drugs that interfere with enterohepatic recirculation
•CellCept should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome
•Gastrointestinal bleeding (requiring hospitalization) has been observed
•During treatment with CellCept, avoid the use of live attenuated vaccines and advise patients that vaccinations may be less effective
•Care should be taken if CellCept Oral Suspension is administered to patients with phenylketonuria
ADVERSE REACTIONS
•The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections, eg, opportunistic infections (see WARNINGS in full Prescribing Information). Phlebitis and thrombosis have been reported with intravenous administration. Please refer to the full Prescribing Information for additional ADVERSE REACTIONS.